Paraspinal Block in Nonspecific Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Sham Lidocaine
Standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion criteria:
- Age between 20 to 60 years;
- Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;
- Moderate to severe pain: visual analog scale (VAS) > 4;
- Diagnosis of chronic nonspecific low back pain;
- MiniMental test (MEEM) between 24 and 30;
- Availability to comply with the visits;
- Agree with signing the Informed Consent Form
Exclusion criteria:
- Severe psychiatric disease that requires psychiatric care;
- Neurological disorders (lumbosciatic pain);
- Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology
- Concurrent rheumatic disease
- History of allergy to lidocaine (used for paraspinal blocks)
- Labor problems
- History of surgery on the lumbar spine
- No availability to visit the clinic for treatment and evaluations.
Sites / Locations
- Hospital das Clinicas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Lidocaine
Sham lidocaine
Standard treatment only
Arm Description
Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.
Sham Injection, without lidocaine, combined with standard treatment.
The only intervention is the standard treatment. No lidocaine or shame injection was used.
Outcomes
Primary Outcome Measures
Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1
Secondary Outcome Measures
Change from baseline in pain on the Brazilian Roland-Morris tool at week 1
Change from baseline in pain on the Brazilian Roland-Morris tool at week 12
Change from baseline in pain on the visual analog scale (VAS) score for pain
Full Information
NCT ID
NCT02387567
First Posted
May 22, 2014
Last Updated
March 12, 2015
Sponsor
Marta Imamura
Collaborators
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02387567
Brief Title
Paraspinal Block in Nonspecific Low Back Pain
Official Title
Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Imamura
Collaborators
Spaulding Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.
Detailed Description
This trial was conducted in the Department of Rehabilitation, Hospital das Clinicas, University, of Sao Paulo Medical School, one of the largest rehabilitation centers in Brazil. The trial was initiated in January of 2007 and close to enrollment in January of 2013. Investigators included patients with a diagnosis of chronic nonspecific low back pain who were referred from various clinics in São Paulo that were linked to this rehabilitation center. Thus, patients were referred primarily by physiatrists, general practitioners, neurologists, orthopedic surgeons, and physiotherapists.
Participants were randomized to receive: (i) paraspinal lidocaine injection (LID-INJ) and standard treatment, (ii) sham lidocaine injection (SH-INJ) and standard treatment, or (iii) standard treatment only (STD-TTR). Randomization was performed using a computerized random number generator.
Assessments The evaluations were performed by an independent and blinded appraiser before treatment, after 1 week, and 3 months after the end of the applications. Baseline assessments consisted of a demographic and baseline clinical assessment [gender, age, occupation, duration of pain (months), pain intensity, associated diseases, and usual occupation] and a physical examination [measurements of weight and height to calculate body mass index (BMI)].
Primary Outcome Measure The primary outcome measure was the visual analog scale (VAS) score for pain. The VAS comprised a 10-cm ruler from 0 to 10, with 0 corresponding to no pain and 10 corresponding to maximum pain. Patients were asked to rate their average pain in the preceding 24 hs.
Secondary Outcome Measures Investigators also measured low back pain using the Brazilian Roland-Morris tool, which consisted of a specific questionnaire to assess function in patients with low back pain and has been validated in Brazil. Scores range from 0 to 24, wherein higher scores reflect greater disability due to low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.
Arm Title
Sham lidocaine
Arm Type
Sham Comparator
Arm Description
Sham Injection, without lidocaine, combined with standard treatment.
Arm Title
Standard treatment only
Arm Type
Active Comparator
Arm Description
The only intervention is the standard treatment. No lidocaine or shame injection was used.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
3ml lidocaine 1% Injection
Intervention Description
Paraspinal block with 3ml lidocaine injection at 1%.
Intervention Type
Drug
Intervention Name(s)
Sham Lidocaine
Other Intervention Name(s)
3ml sham injection
Intervention Description
Sham injection, without lidocaine.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
Lowback pain standard treatment
Intervention Description
Standard treatment only, without lidocaine or sham injection.
Primary Outcome Measure Information:
Title
Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1
Time Frame
Baseline, week 1
Secondary Outcome Measure Information:
Title
Change from baseline in pain on the Brazilian Roland-Morris tool at week 1
Time Frame
Baseline, week 1
Title
Change from baseline in pain on the Brazilian Roland-Morris tool at week 12
Time Frame
baseline, week 12
Title
Change from baseline in pain on the visual analog scale (VAS) score for pain
Time Frame
Baseline, week 12
Other Pre-specified Outcome Measures:
Title
Adverse effects questionnaire
Time Frame
Immediately after intervention and 3 months post application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age between 20 to 60 years;
Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;
Moderate to severe pain: visual analog scale (VAS) > 4;
Diagnosis of chronic nonspecific low back pain;
MiniMental test (MEEM) between 24 and 30;
Availability to comply with the visits;
Agree with signing the Informed Consent Form
Exclusion criteria:
Severe psychiatric disease that requires psychiatric care;
Neurological disorders (lumbosciatic pain);
Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology
Concurrent rheumatic disease
History of allergy to lidocaine (used for paraspinal blocks)
Labor problems
History of surgery on the lumbar spine
No availability to visit the clinic for treatment and evaluations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MD
Organizational Affiliation
Instituto de Medicina Física e Reabilitação HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26828801
Citation
Imamura M, Imamura ST, Targino RA, Morales-Quezada L, Onoda Tomikawa LC, Onoda Tomikawa LG, Alfieri FM, Filippo TR, da Rocha ID, Neto RB, Fregni F, Battistella LR. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial. J Pain. 2016 May;17(5):569-76. doi: 10.1016/j.jpain.2016.01.469. Epub 2016 Jan 30.
Results Reference
derived
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Paraspinal Block in Nonspecific Low Back Pain
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